Dangerous Drugs Often Get Past FDA Expedited Approval Process: Study

A new study by researchers from Harvard highlights the risk of unsafe drugs being allowed onto the market since the passage of an act that allowed pharmaceutical companies to pay a fee for expedited drug approvals, finding that the fast-track system has resulted in an increased number of drug recalls in recent years.

The Prescription Drug User Fee Act (PDUFA) was enacted in 1992, allowing drug manufacturers to get their new medications on the market faster by paying a fee to speed up the regulatory review process. The law has led to a decrease in the average drug approval time from 34 months to 16 months, but may be resulting in large numbers of patients being exposed to dangerous drugs before side effects are recognized.

In a study published in the August issue of the medical journal Health Affairs, Harvard researchers looked at drug approvals by the FDA over the last 35 years, finding that a greater rate of drugs recalls are being issued since the passage of PDUFA.

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Between 1975 and 2009, the FDA approved 748 new molecular entities (NMEs) that were not over-the-counter drugs. Researchers found that 114 of them subsequently received black box warnings, and 32 were pulled from the market.

Researchers also found that drugs approved after PDUFA was enacted were more likely to need a black box warning, the strongest label warning the FDA can require, after they were made available to the public. They also found that they were more likely to be pulled from the market for health reasons. 

According to the researchers, newer drugs are 35% more likely to get a black box warning or be withdrawn completely since the expedited process was put into place.

One well-known example was Merck’s nonsteroidal anti-inflammatory drug (NSAID) Vioxx, which was recalled in 2004, just five years after it was introduced. Amid aggressive direct-to-consumer marketing by the drug maker, Vioxx quickly became a popular and widely used medication. As a result, the medication was linked to between 88,000 and 140,000 cases of serious heart disease before it was recalled.

“Unfortunately, danger signals are not being detected early enough to prevent millions of patients from being exposed to unsafe drugs,” the researchers concluded. “Drugs approved after the enactment of PDUFA were more likely to receive a black-box warning or be withdrawn. Why might this be the case? One theory is that PDUFA-imposed deadlines may have caused rushed approvals, resulting in an increase in safety problems that were recognized only after a drug was already in use.”

Researchers indicate that the rushed approvals may prevent the detection of serious drug side effects, resulting in patients being exposed for months or years to dangerous drugs before they are withdrawn or the proper warnings are put into place. They also theorized that faster approval times may compromise the quality of clinical trial evidence.

The study’s authors suggested that patients and doctors wait until a drug has been on the market for a considerable amount of time before making it a go-to treatment.

The consumer watchdog group, Public Citizen, which advocates a grace period for new drugs, touted the study’s findings in a press release this week.

“The FDA is under constant pressure to rush new drugs through the pipeline to approval. In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through,” lead study author Cassie Frank, MD, an instructor of medicine at Harvard medical School and a physician in the Cambridge Health Alliance said in the press release. “By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal. As a doctor, I try to keep my patients safe by avoiding new drugs, when there are similar, older ones available.”


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